Influence of Whole Body Vibration Compared to Conventional Physiotherapy in Patients With Gonarthrosis - Full Text View

Sponsor:	University of Cologne
Information provided by (Responsible Party):	Dr. Gregor Stein, University of Cologne
ClinicalTrials.gov Identifier:	NCT01037972

Purpose

40 patients with osteoarthritis of the knee will be randomly assigned to conventional physiotherapy on the one and whole body vibration exercises on the other hand. The duration of the training will be 6 weeks, three times a week.

The outcome will be measured by WOMAC and SF-12 scores relating to pain and quality of life. The second outcome criteria will be a motion analysis and balance testing before and after the training.

The follow-up is 26 weeks.

Condition	Intervention
Osteoarthritis	Behavioral: Conventional physiotherapy Behavioral: Whole body vibration

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
Official Title:	Influence of Whole Body Vibration Compared to Conventional Physiotherapy in Patients With Gonarthrosis

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

Further study details as provided by University of Cologne:

Primary Outcome Measures:

Pain Reduction [ Time Frame: 6 weeks after inclusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Motion analysis [ Time Frame: 6 weeks after inclusion ] [ Designated as safety issue: No ]
Pain reduction [ Time Frame: 12 weeks after inclusion ] [ Designated as safety issue: No ]
Pain reduction [ Time Frame: 26 weeks after inclusion ] [ Designated as safety issue: No ]
Motion analysis [ Time Frame: 12 weeks after inclusion ] [ Designated as safety issue: No ]
Motion analysis [ Time Frame: 26 weeks after inclusion ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: 6 weeks after inclusion ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: 12 weeks after inclusion ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: 26 weeks after inclusion ] [ Designated as safety issue: No ]

Enrollment:	40
Study Start Date:	March 2010
Study Completion Date:	October 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Whole body vibration	Behavioral: Whole body vibration 3 times weekly 30 minutes of exercises on a whole body vibration device to strengthen muscular strength and improve muscular balance in the lower extremity. Other Name: Galileo Whole body vibration
Conventional physiotherapy	Behavioral: Conventional physiotherapy 3 times weekly 30 minutes of conventional physiotherapy to strengthen muscular strength and balance in the lower extremity. Other Name: Galileo

Eligibility

Ages Eligible for Study:	30 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patients with osteoarthritis of the knee.

Criteria

Inclusion Criteria:

30-80 years old
WOMAC 30-70 mm (VAS)
Gonarthrosis (Kellgren/Lawrence) II-III

Exclusion Criteria:

WOMAC >70 mm (VAS)
Endoprosthesis in lower extremity
BMI >40 kg/m2

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01037972

Locations

Germany
University Hospital of Cologne
Cologne, Germany, 50924

Sponsors and Collaborators

University of Cologne

Investigators

Principal Investigator:	Kourosh Zarghooni, MD	University of Cologne
Study Director:	Gregor Stein, MD	University of Cologne

More Information

Additional Information:

University Hospital of Cologne This link exits the ClinicalTrials.gov site

No publications provided by University of Cologne

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Stein G, Knoell P, Faymonville C, Kaulhausen T, Siewe J, Otto C, Eysel P, Zarghooni K. Whole body vibration compared to conventional physiotherapy in patients with gonarthrosis: a protocol for a randomized, controlled study. BMC Musculoskelet Disord. 2010 Jun 21;11:128.

Responsible Party:	Dr. Gregor Stein, Dr. med, University of Cologne
ClinicalTrials.gov Identifier:	NCT01037972 History of Changes
Other Study ID Numbers:	Galileo, 2009-017617-29
Study First Received:	December 22, 2009
Last Updated:	October 7, 2011
Health Authority:	Germany: Ethics Commission

Keywords provided by University of Cologne:

Galileo
Whole body vibration
Osteoarthritis
Knee
Physiotherapy

Additional relevant MeSH terms:

Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 24, 2012